EpicentRx to Present AdAPT-001 at 2024 ASCO Annual Meeting

EpicentRx, a biopharmaceutical company in the clinical-stage of development, has made a significant announcement regarding their ongoing Phase 2 BETA PRIME clinical trial. The trial is investigating the efficacy of AdAPT-001, a leading TGF-β ligand trap, in combination with an immune checkpoint inhibitor (ICI) in patients with sarcomas and triple negative breast cancer (TNBC) that exhibit resistance to standard checkpoint inhibitors.

The trial has been noteworthy enough to garner an invitation for Dr. Anthony P. Conley, a sarcoma specialist from MD Anderson Cancer Center (MDACC) and the lead principal investigator, to present at the upcoming American Society of Clinical Oncology (ASCO) meeting. This invitation underscores the importance and promising results of the trial, which has enrolled nearly 70 patients. The trial has reported complete and durable partial responses, even in tumor types that had previously shown resistance to checkpoint inhibitors. Some patients have been on this treatment regimen for almost two years, indicating a sustained benefit.

A crucial aspect of the trial's success is the safety profile of AdAPT-001. To date, no dose-limiting toxicities or serious adverse events related to AdAPT-001 have been observed. Only one immune-related adverse event has been reported, suggesting that AdAPT-001 may mitigate the immune-related side effects typically associated with ICIs. This is significant as it indicates that AdAPT-001 could potentially protect normal tissues from ICI-mediated immune attacks while still targeting cancerous tissues.

AdAPT-001 functions by neutralizing TGF-β, a cytokine involved in various immunosuppressive pathways. By inhibiting TGF-β, AdAPT-001 enhances the effectiveness of ICIs, even in patients who have not responded to them previously. The BETA PRIME trial, conducted at multiple centers and led by Dr. Conley and Dr. Lucy B. Kennedy from the Cleveland Clinic, administers AdAPT-001 bi-weekly in combination with an ICI.

Dr. Conley expressed his excitement about presenting the data at ASCO, noting that being selected for an oral presentation is a prestigious recognition of the trial’s importance. He credited the trial’s success to the patients, the team at EpicentRx, and the collaborative effort from MDACC.

The presentation at ASCO will delve into the details of the trial, which is officially titled "Phase 1/2 study of the TGF-β-trap-enhanced oncolytic adenovirus, AdAPT-001, plus an immune checkpoint inhibitor for patients with immune refractory cancers." The abstract for this presentation is available on the ASCO website.

AdAPT-001 stands out as the most clinically advanced TGF-β ligand trap. It is designed to neutralize specific isoforms of TGF-β, thereby reducing the cytokine's profibrotic, proangiogenic, prohypoxic, and immunosuppressive effects. This makes resistant tumors more susceptible to checkpoint blockade therapy.

The BETA PRIME trial has shown that combining AdAPT-001 with checkpoint inhibitors not only improves the toxicity profile but also avoids the dose-limiting toxicities and serious adverse events typically seen with such treatments. No dose reductions have been necessary, further highlighting the therapy's tolerability.

EpicentRx is making strides in addressing diseases with high unmet medical needs through innovative therapies like AdAPT-001 and RRx-001. Their commitment to advancing drug development positions them at the forefront of the biopharmaceutical industry.

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